The following specification describes my invention of a new steroid drug delivery system. The invention is a new method and formulation useful for menstrual cycle regulation to achieve ovulation control and to treat menstrual dysfunction. More particularly, my invention is a follicular-luteal sex steroid replacement which may be adapted to the specific presenting clinical state of the individual patent. Thus, the method for sex steroid replacement of the invention is useful in the management of clinical states of menstrual irregularity, menstrual dysfunction, ovulation pain, primary dysmenorrhea, and premenstrual tension syndrome. The method is also useful as a sex steroid drug delivery system for pregnancy spacing where sex steroids are widely used today.
Opportunities for undesirable clinical, endocrine and metabolic side effects, which have resulted from exogenous steroid dosages administered in prior art contraceptive methods and formulations are reduced by the present invention. The hepatic, morphologic, metabolic, and endocrine adverse consequences from sex steroid treatment cycles are reduced by steroid administration in accordance with the present invention. Future ovulation disturbance in patients administered sex steroids for menstrual contraception purposes is also minimized.
In addition, the present invention provides a method and formulation for the delivery of steroid drugs which allows a rational decrease of exogenous estrogen in sex steroid menstrual cycle management. The method minimizes both the dose and days of administration of exogenous estrogen and minimizes the days of combination exogenous estrogen and progestin in sex steroid treatment cycles. The invention provides adequate menstrual cycle control and physiologic correction of menstrual dysfunction in diverse clinical problems that no current estrogen/progestin formulation adequately manages in a rational physiologic manner.